Draft for consultation
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Patient Group Directions
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NICE good practice guidance
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Draft for consultation, April 2013
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Patient Group Directions: Good practice guidance DRAFT (April 2013)
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Contents
2
1
Introduction................................................................................................ 4
3
1.1
Purpose of this guidance .................................................................... 4
4
1.2
Audience for this guidance.................................................................. 4
5
1.3
Scope.................................................................................................. 4
6
1.4
Definition of a Patient Group Direction ................................................ 5
7
1.5
Prescribing, supplying and administering medicines .......................... 5
8
1.6
Legal framework governing the use of Patient Group Directions ........ 7
9
2
Recommendations .................................................................................. 12
10
2.1
Considering the need for a Patient Group Direction ......................... 12
11
2.2
Obtaining agreement to develop a Patient Group Direction .............. 12
12
2.3
Developing Patient Group Directions ................................................ 12
13
2.4
Authorising Patient Group Directions ................................................ 12
14
2.5
Using Patient Group Directions ......................................................... 12
15
2.6
Reviewing and updating Patient Group Directions ............................ 12
16
2.7
Training and competency.................................................................. 12
17
2.8
Organisational governance ............................................................... 12
18
3
Evidence and recommendations ............................................................. 13
19
3.1
Considering the need for a Patient Group Direction ......................... 15
20
3.2
Obtaining agreement to develop a Patient Group Direction .............. 24
21
3.3
Developing Patient Group Directions ................................................ 30
22
3.4
Authorising Patient Group Directions ................................................ 35
23
3.5
Using Patient Group Directions ......................................................... 42
24
3.6
Reviewing and updating Patient Group Directions ............................ 48
25
3.7
Training and competency.................................................................. 52
26
3.8
Organisational governance ............................................................... 57
27
4
How this guidance has been developed .................................................. 62
28
4.1
Guidance Development Group ......................................................... 62
29
4.2
Literature search strategy ................................................................. 62
30
4.3
Additional evidence ........................................................................... 62
31
Appendix A Glossary ..................................................................................... 64
32
Appendix B Key resources ............................................................................. 70
33
Appendix C The Guidance Development Group and NICE project team ....... 71
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Guidance Development Group ................................................................... 71
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NICE project team ...................................................................................... 72
3
Appendix D Literature search......................................................................... 73
4
Search strategy .......................................................................................... 73
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Search questions ........................................................................................ 73
6
Sources searched ...................................................................................... 74
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1
Introduction
2
1.1
Purpose of this guidance
3
The purpose of this guidance is to provide good practice recommendations for
4
the systems and processes used when commissioners and providers of NHS
5
services are considering the need for, developing, authorising, using and
6
updating Patient Group Directions (PGDs). This guidance also covers
7
governance arrangements with the aim of ensuring patients receive safe and
8
appropriate care and timely access to medicines, in line with legislation.
9
1.2
Audience for this guidance
10
This guidance is for individual people and organisations who are considering
11
the need for, developing, authorising, using and updating PGDs. It is written in
12
the context of the NHS in England, including independent organisations or
13
contractors who are commissioned to provide NHS services. It will also be
14
applicable as NICE guidance, as appropriate, to some of the devolved
15
administrations.
16
1.3
17
The scope covers the legislation, systems and processes used when
18
commissioners and providers of NHS services are considering the need for,
19
developing, authorising, using and updating PGDs. This includes NHS
20
organisations, local authorities (in England), and any NHS-commissioned
21
services provided by non-NHS organisations, such as:
22
 independent organisations (for example, independent hospitals)
23
 independent contractors (for example, community pharmacies)
24
 voluntary and charitable agencies (for example, hospices).
25
When considering the appropriateness of PGDs, the Guidance Development
26
Group (GDG) considered other options for supplying and/or administering
27
medicines to patients (see section 1.5). However, recommendations have not
28
been made in relation to these options.
Scope
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This guidance does not include shared practice examples or other
2
approaches for implementing the good practice recommendations.
3
1.4
4
A PGD is defined in Health Service Circular (HSC 2000/026) as:
Definition of a Patient Group Direction
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‘A written instruction for the supply or administration of medicines to
6
groups of patients who may not be individually identified before
7
presentation for treatment’.
8
PGDs provide a legal framework that allows the supply and/or administration
9
of a specified medicine(s), by named authorised health professionals, to a
10
pre-defined group of patients needing treatment for a condition described in
11
the PGD, without the need for a prescription or an instruction from a
12
prescriber. Using a PGD is not a form of prescribing.
13
This definition should not be interpreted as indicating that the patient should
14
not be identified. Patients may or may not be known to the service (see
15
section 3.1).
16
1.5
17
Understanding the distinction between prescribing, supplying and
18
administering medicines to patients is important for people and organisations
19
involved with PGDs. There are no legal definitions that distinguish between
20
prescribing, supplying, dispensing and administering a medicine. The
21
definitions used for the purpose of this guidance are given in appendix A.
22
Historically, a doctor (or dentist) would identify that a medicine(s) was needed
23
as part of the care pathway and prescribe a medicine for the patient. A
24
pharmacist would then dispense the medicine(s) against the prescription and
25
supply the medicine(s) to the patient.
26
This traditional ‘medical model’ changed in the years after publication of the
27
final Crown report in 1999. Legal frameworks were developed that have
28
allowed services to be redesigned and health professionals to work more
29
flexibly for the benefit of patients. In particular, prescribing responsibilities
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Prescribing, supplying and administering medicines
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have been extended to allow other health professionals to complete additional
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training and qualify as non-medical prescribers. In addition, these frameworks
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allow medicines to be supplied and/or administered directly by a health
4
professional, without the need for prescribing at some key steps in a care
5
pathway.
6
As a result of these changes, there are now several legal options for
7
prescribing, supplying and administering medicines. These are:
8
 Independent prescribing – the prescriber takes responsibility for the clinical
9
10
assessment of the patient, establishing a diagnosis, the clinical
management needed and prescribing of therapies.
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 Supplementary prescribing – a voluntary partnership between a doctor or
12
dentist and a supplementary prescriber, to prescribe within an agreed
13
patient-specific clinical management plan with the patient’s agreement.
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 Patient Specific Directions (PSDs) – written instructions from an
15
independent prescriber for a medicine to be supplied and/or administered
16
to a named patient.
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 Patient Group Directions (PGDs) – see section 1.4 for definition.
18
 Exemptions from medicines legislation, for example:
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 a range of exemptions allow certain groups of health professionals, such
20
as chiropodists and podiatrists, midwives, paramedics, and optometrists,
21
to sell, supply and administer particular medicines directly to patients
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 occupational health schemes
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 pandemic influenza
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 parenteral medicines that can be administered in an emergency by any
25
person without the directions of a prescriber
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 civil contingencies.
27
These exemptions are distinct from prescribing and the arrangements for
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PGDs.
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 Emergency supplies – in an emergency and under certain conditions a
pharmacist working in a registered pharmacy can supply a prescription-only
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medicine (POM) to a patient without a prescription, if requested by a
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prescriber or the patient1.
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These options provide organisations with a range of alternatives to consider
4
when making decisions about the safest and most appropriate way for
5
patients to get the medicines they need.
6
Purpose of Patient Group Directions
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Evidence identified in developing this guidance confirmed that the majority of
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clinical care should be provided on an individual, patient-specific basis. This
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means that independent prescribing remains the most appropriate option for
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the majority of care. Supplying and/or administering medicines under PGDs
11
should be reserved for situations where this offers an advantage for patient
12
care without compromising patient safety, and where it is consistent with
13
appropriate professional relationships and accountability2.
14
The GDG agreed that the purpose of using a PGD was to:
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 deliver effective patient care that is appropriate in a pre-defined clinical
situation, without compromising patient safety
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 offer a significant advantage to patient care by improving access to
appropriate medicines
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 provide equity in the availability and quality of services when other options
for supplying and/or administering medicines are not available
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 provide a safe legal framework to protect patients
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 reduce delays in treatment
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 maximise the skills of a range of health professionals.
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1.6
Legal framework governing the use of Patient Group
Directions
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26
Legislation establishing PGDs was introduced in 2000 and the Health Service
27
Circular (HSC 2000/026) provided additional guidance. The current legislation
1
Royal Pharmaceutical Society. Medicines, Ethics and Practice. The professional guide for
pharmacists. Edition 36 July 2012
2
th
NHS Executive. Health Service Circular (HSC 2000,026) 9 August 2000
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for PGDs is included in The Human Medicines Regulations 2012, which came
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into force in August 2012. This legislation was amended in April 2013 to
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reflect changes to NHS organisational structures in England, as a result of the
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Health and Social Care Act 2012.
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The amended legislation also incorporated transitional arrangements to
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ensure the continuing validity and effect of PGDs during organisational
7
change, and to ensure that individual people and organisations act within the
8
legal framework. These arrangements allowed PGDs to remain legal when the
9
original authorising body (for example, a primary care trust [PCT]) was
10
abolished, and until expiry or authorisation by the new authorising body (for
11
example, a clinical commissioning group (CCG) or local authority). See the
12
national PGD website for further information.
13
Authorising Patient Group Directions
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Legislation requires that a PGD must be signed by a doctor (or dentist) and a
15
pharmacist.
16
PGDs must also be signed on behalf of the authorising body with which a
17
contract or agreement for the provision of those services has been made, or
18
which provides those services, as set out in the legislation. In the NHS these
19
authorising bodies are:
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 CCGs
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 local authorities
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 NHS trusts or NHS foundation trusts
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 the NHS Commissioning Board.
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In addition, the following independent organisations can also authorise PGDs
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for NHS-commissioned services:
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 dental practices and clinics
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 organisations operating as an independent medical agency and where the
28
registered provider at the agency is registered in compliance with section
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10 of the Health and Social Care Act 2008 in respect of 1 or more of the
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following regulated activities:
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 treatment of disease, disorder or injury
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 assessment or medical treatment of persons detained under the Mental
5
Health Act 1983
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 surgical procedures
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 diagnostic and screening procedures
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 maternity and midwifery services
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 family planning.
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Health professionals eligible to use Patient Group Directions
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Legislation requires that PGDs must only be used by the following, registered
12
health professionals:
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 ambulance paramedics
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 dental hygienists and dental therapists
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 dietitians
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 health visitors
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 midwives
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 nurses
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 occupational therapists
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 optometrists
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 orthoptists
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 pharmacists
23
 physiotherapists
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 podiatrists and chiropodists
25
 prosthetists and orthotists
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 radiographers
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 speech and language therapists.
28
Individual health professionals must be named and authorised to practice
29
under a PGD. Also see section 3.1.
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Medicines excluded from PGDs
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Legislation excludes the use of the following medicines in a PGD:
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 unlicensed medicines including:
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 the mixing of 2 licensed medicines to form 1 new (unlicensed) product,
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unless 1 is an vehicle for administration, such as water for injection
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 special manufactured medicines
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 dressings, appliances and devices
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 radiopharmaceuticals
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 abortifacients, such as mifepristone
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 controlled drugs, with the exception of the following controlled drugs that
11
may be considered:
12
 morphine and diamorphine, listed in schedule 2 of the Misuse of Drugs
13
Regulations (2001) by registered nurses and pharmacists for the
14
immediate necessary treatment of a sick or injured person (except for
15
treating addiction)
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17
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 midazolam, listed in schedule 3 of the Misuse of Drugs Regulations
(2001)
 all drugs, such as benzodiazepines and ketamine, that are listed in
19
schedule 4 of the Misuse of Drugs Regulations (2001), except anabolic
20
steroids and any injectable preparation used for treating addiction
21
22
 all drugs, such as codeine, that are listed in schedule 5 of the Misuse of
Drugs Regulations (2001).
23
Information to be included in a Patient Group Direction
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Legislation requires that each PGD must contain the following information:
25
 the period during which the direction is to have effect
26
 the description or class of medicinal product to which the direction relates
27
 the clinical situations which medicinal products of that description or class
28
may be used to treat or manage in any form
29
 whether there are any restrictions on the quantity of medicinal product that
30
may be sold or supplied on any one occasion and, if so, what restrictions
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 the clinical criteria under which a person is to be eligible for treatment
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 whether any class of person is excluded from treatment under the direction
and, if so, what class of person
 whether there are circumstances in which further advice should be sought
from a doctor or dentist and, if so, what circumstances
 the pharmaceutical form or forms in which medicinal products of that
description or class are to be administered
 the strength, or maximum strength, at which medicinal products of that
description or class are to be administered
 the applicable dosage or maximum dosage
10
 the route of administration
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 the frequency of administration
12
 any minimum or maximum period of administration applicable to medicinal
13
products of that description or class
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 whether there are any relevant warnings to note and, if so, what warnings
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 whether there is any follow up action to be taken in any circumstances and,
16
if so, what action and in what circumstances
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 arrangements for referral for medical advice
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 details of the records to be kept of the supply, or the administration, of
19
products under the direction.
20
Other legislation
21
Legislation for the labelling of medicines applies to all supplies of medicines,
22
including those supplied under PGDs. Separate requirements exist for POMs
23
and for Pharmacy (P) and General Sales List (GSL) medicines. See appendix
24
A for definitions.
25
A manufacturer’s patient information leaflet must be provided to patients who
26
have a medicine supplied under a PGD.
27
Standard prescription charge rules and exemptions also apply to patients
28
receiving a supply of medicine(s) under a PGD from the NHS, but do not
29
apply when medicines are administered under a PGD.
30
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2
Recommendations
2
This good practice guidance has been developed for individual people and
3
organisations considering the need for, developing, authorising, using and
4
updating Patient Group Directions (PGDs).
5
The recommendations for good practice have been developed by the PGD
6
Guidance Development Group (GDG), using relevant legislation, guidance
7
and policy as the foundation for good practice. See appendix B for a list of key
8
resources used in developing this guidance.
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[Drafting note: see sections 3.1 to 3.8 for recommendations. All
10
recommendations will be inserted into this section on final publication].
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2.1
Considering the need for a Patient Group Direction
12
2.2
Obtaining agreement to develop a Patient Group
Direction
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14
2.3
Developing Patient Group Directions
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2.4
Authorising Patient Group Directions
16
2.5
Using Patient Group Directions
17
2.6
Reviewing and updating Patient Group Directions
18
2.7
Training and competency
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2.8
Organisational governance
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21
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3
Evidence and recommendations
2
When reviewing the evidence gathered for this guidance, the GDG concluded
3
that the key principles in each of the following areas needed careful
4
consideration:
5
 considering the need for a Patient Group Direction (PGD)
6
 obtaining agreement to develop a PGD
7
 developing PGDs
8
 authorising PGDs
9
 using PGDs
10
 reviewing and updating PGDs
11
 training and competency
12
 organisational governance.
13
An overview of the process agreed by the GDG is shown in figure 1. Details
14
may vary depending on how local services are designed. Although this
15
guidance is written in the context of the NHS in England, the GDG agreed that
16
these principles are applicable to independent organisations or contractors
17
who are commissioned to provide NHS services, and to some of the devolved
18
administrations.
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2
Figure 1. Overview of the process for considering the need for,
developing, authorising, using and updating PGDs.
Consider the need for a PGD
Stakeholder engagement
Stakeholder engagement
Develop proposal
PGD approval group
considers proposal
Proposal rejected
Governance arrangements
Training and competency
Appeal
Proposal accepted
Establish PGD working group
Appeal upheld
Appeal rejected
Stakeholder engagement
PGD not developed
Develop PGD using local template
Amendments needed
Authorisation by doctor (or dentist),
pharmacist and other professional
groups representative
Authorisation by authorising body
Communication and dissemination
Authorisation of health professionals
to practice under PGD
PGD in use to deliver service
Monitoring and evaluation
Stakeholder engagement
3
PGD no longer needed to
deliver service
Review and updating
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3.1
Considering the need for a Patient Group Direction
2
The GDG identified the importance of firmly establishing local governance
3
arrangements between the commissioning and provider organisation(s) with
4
clear lines of responsibility and accountability for each PGD. This should be
5
undertaken at the earliest opportunity when considering the need for a PGD to
6
avoid possible delays in developing and delivering appropriate services (see
7
section 3.8).
8
Exploring the options for supplying and/or administering medicines
9
The GDG found evidence that the majority of clinical care involving supplying
10
and/or administering medicines should be provided on an individual, patient-
11
specific basis (see section 1.5). The GDG was aware of PGDs being used to
12
deliver a service when independent prescribing would be a more appropriate
13
option, for example when prescribers were not available at the required time.
14
The GDG considered that barriers to developing independent prescribing,
15
such as a lack of allocated funding and staff commitment, may have
16
contributed to the unnecessary or inappropriate development of PGDs.
17
Even in circumstances when it may be legally possible, the GDG agreed that
18
a PGD may not be the preferred and safest approach to individual situations
19
of providing patients with the medicine(s) they need. The GDG also found
20
evidence that in some circumstances different options for prescribing, supply
21
and/or administering medicines can be beneficial when used in combination,
22
subject to the appropriate training and competencies. See box 1 for examples
23
of different options which may be available for supplying and administering
24
influenza vaccines.
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Box 1 Options for supplying and/or administering influenza vaccines
Options for supplying and/or administering influenza vaccines include:
 A district nurse who may administer to a patient in their home after a
prescription and supply from a community pharmacy or a Patient Specific
Direction (PSD) from a GP.
 A healthcare assistant who may administer in a flu clinic after a PSD from a
GP. A PGD would not be legally permitted (see section 1.6).
 A community pharmacist who may administer using a PGD as part of an
NHS-commissioned enhanced service.
2
3
The GDG found evidence that PGDs are often used in the NHS in first contact
4
settings, when patients seek unscheduled care such as in:
5
 accident and emergency departments
6
 ambulance services
7
 community pharmacies
8
 contraception and sexual health clinics
9
 minor injuries units
10
 walk-in centres
11
 out-of-hours services.
12
However, the GDG agreed that the setting alone should not determine
13
whether a PGD is the most appropriate option for supplying and/or
14
administering the medicine.
15
The GDG was aware of national PGD website tools to help identify when a
16
PGD may be the most appropriate option, for example ‘To PGD or not to
17
PGD’.
18
The GDG concluded that these tools should be utilised when considering the
19
need for a PGD. In general, the need for a PGD in a specific clinical situation
20
should be considered locally. A comprehensive approach should include
21
reviewing the care pathway and exploring all the options for prescribing,
22
supplying and/or administering medicines.
23
In circumstances when there are insufficient prescribers, the GDG accepted
24
that PGDs may be needed as an interim option while independent prescribing
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is developed, if that is the preferred approach. However, the GDG agreed that
2
governance arrangements would need to be in place (see section 3.8). In
3
addition, organisations may need to develop or review their strategic
4
medicines policy to develop independent prescribing locally. The GDG
5
concluded that PGDs should not be seen as a direct substitute for
6
independent prescribing.
7
Health professionals eligible to use Patient Group Directions
8
The GDG noted that legislation requires that only specific registered health
9
professionals can use PGDs (see section 1.6). Most of the evidence identified
10
from the literature search related to PGD use by nurses and pharmacists.
11
The GDG was aware of examples of other groups of healthcare workers using
12
PGDs that were not eligible, such as healthcare assistants, student health
13
professionals and registered health professionals not listed in PGD legislation.
14
Because this is not within the legal requirements for PGDs, the GDG agreed
15
that this use should be identified when organisations develop or review their
16
strategic medicines policy.
17
The GDG was also aware that legislation requires that health professionals
18
using PGDs can only do so as named individuals and are not able to delegate
19
their responsibility to another person (see section 3.5).
20
Organisations using Patient Group Directions
21
The GDG was aware of the range of organisations and services that can
22
currently use PGDs to provide NHS-funded care. These are:
23
 NHS trusts and foundation trusts
24
 primary care organisations, such as clinical commissioning group (CCGs)
25
 NHS-commissioned services including:
26
 services provided by the private, voluntary or charitable sectors
27
 urgent care services, such as out-of-hours services and walk-in centres
28
 services provided by independent contractors, such as GP and dental
29
practices and community pharmacies.
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Medicines that can be considered for a Patient Group Direction
2
The GDG was aware of legislation governing which medicines can be
3
included in a PGD (see section 1.6). The GDG also reviewed the evidence
4
and considered the appropriateness of other medicines that may be
5
considered for supply and/or administration using a PGD:
6
 off-label use of medicines may be considered, if such use is exceptional
7
and supported by best clinical practice, such as NICE guidance
8
 black triangle medicines may be considered, provided such use is
9
exceptional and supported by best clinical practice, such as Joint
10
Committee on Vaccination and Immunisation (JCVI) advice relating to the
11
use of vaccines
12
 particular caution should be exercised in any decision to draw up PGDs
13
relating to antibacterials. Microbial resistance is a public health matter of
14
major importance and great care should be taken to ensure that their
15
inclusion in a PGD is absolutely necessary and will not jeopardise
16
strategies to combat increasing resistance.
17
The GDG recognised that specifying a dosage range so the health
18
professional could select the correct dose for a patient was appropriate in a
19
PGD. However, the GDG did not consider frequent individual adjustment of
20
dosage using a PGD to represent good practice and agreed that prescribing
21
or a PSD would be a more appropriate option.
22
The GDG also noted that dose adjustments should not be made under a PGD
23
when a medicine is in a patient’s possession unless specified at the point of
24
supply.
25
The GDG agreed that the original intention of PGDs was not to use them for
26
‘complex’ medicines, including medicines needing frequent dose adjustments,
27
frequent or complex monitoring, or high-risk medicines. The GDG supported
28
the original intention and agreed that the risks of using a complex medicine in
29
a PGD outweighed the benefits and alternative options should be used.
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The GDG received reports describing the growth in the use of PGDs in
2
settings, for indications and for medicines where good practice was not being
3
followed. For example, the GDG was aware of evidence that some radiology
4
services were using PGDs for administering contrast media. The GDG
5
concluded that these were complex medicines and if a PGD was being used
6
in such circumstances it would be appropriate to review its use and consider
7
other options, such as prescribing.
8
The GDG found evidence that more than 1 medicine could be included within
9
a PGD. However, the GDG agreed that good practice was likely to be
10
represented by including a single medicine. The GDG acknowledged that
11
including more than 1 medicine may be appropriate in some circumstances,
12
such as different medicines being options for managing a single condition,
13
provided all legal requirements were included for each drug. For example,
14
levonorgestrel or ulipristal acetate for emergency hormonal contraception.
15
The GDG heard reports of PGDs being used when a PGD is not needed, for
16
example when medicines are classified as General Sales List (GSL) or
17
because of exemptions in legislation for specified medicines for certain groups
18
of health professionals, such as chiropodists and podiatrists, midwives,
19
paramedics and optometrists (see section 1.5). Pharmacy (P) medicines can
20
also be supplied through registered pharmacies, without the need for a PGD.
21
See the national PGD website tool ‘To PGD or not to PGD’ for more
22
information.
23
The GDG agreed that local policies would be more appropriate in these
24
circumstances, with the employing organisation retaining legal responsibility
25
for the actions of its employees.
26
See box 2 for examples of clinical situations when PGDs may be appropriate.
27
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1
Box 2 Clinical situations when PGDs may be appropriate
PGDs may be appropriate when:
 medicine use follows a predictable pattern, such as for patients attending
for contraception
 patients with an acute need seek unscheduled care, such as in a walk-in
centre
 managing a discrete treatment episode where supplying or administering a
medicine is needed, such as treating chlamydia
 there is a homogenous patient group, such as at-risk groups of patients
needing immunisation.
2
See box 3 for examples of clinical situations when PGDs need to be
3
considered carefully.
4
Box 3 Clinical situations when PGDs need to be considered carefully
PGDs should be considered carefully when:
 the medicine is being used off label
 the medicine is a black triangle medicine
 the medicine is a controlled drug (only some controlled drugs are eligible
for consideration)
 the medicine is an injectable preparation for self-administration
 treatment or response to treatment needs careful monitoring
 managing a small number of patients in a specific patient group, because
the appropriate resources and expertise may not be available
 supplying and/or administering a range of medicines to the same patient
(this may be appropriate in some cases when a discrete episode of care
involves treatment with more than 1 medicine).
5
See box 4 for examples of clinical situations when alternative options to PGDs
6
should be used.
7
8
Box 4 Clinical situations when alternative options to PGDs should be
used
Alternative options to PGDs should be used when:
 managing complex long-term conditions, such as hypertension or diabetes
 in a particular setting, significant uncertainty remains about the differential
diagnosis
 an antimicrobial is needed (this may be appropriate in some circumstances,
such as chlamydia treatment in a sexual health clinic)
 the medicine needs frequent dosage adjustments, for example warfarin
 the medicine needs frequent or complex monitoring, for example
immunosuppressants
 the medicine is a high-risk medicine, for example insulin.
9
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1
Recommendations
Recommendation 2.1.1
Explore all the available options for supplying and/or administering medicines
in a specific clinical situation. Consider whether 1 option or a range of options
is appropriate.
Recommendation 2.1.2
Reserve PGDs for the limited situations when this offers an advantage for
patient care, without compromising patient safety, and where it is consistent
with appropriate professional relationships and accountability.
Recommendation 2.1.3
Use the national PGD website tools to consider whether a PGD is necessary.
Do not use PGDs for medicines when exemptions in legislation allow their
supply and/or administration without the need for a PGD.
Recommendation 2.1.4
Consider investing in the training of additional prescribers to redesign services
if necessary, as part of a wider development or review of local medicines
policy.
Recommendation 2.1.5
PGDs must be used only by named, registered health professionals who can
legally supply and/or administer medicines using a PGD.
Recommendation 2.1.6
PGDs must be used only in organisations and services that are legally eligible
to use them within the NHS.
Recommendation 2.1.7
Ensure only a licensed medicine(s) that is legally permitted to be supplied
and/or administered using a PGD is included in a PGD.
Recommendation 2.1.8
Ensure off-label use of a medicine in a PGD is exceptional and justified by
best clinical practice. Clearly state on the PGD that the medicine is being used
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outside the terms of the marketing authorisation. Consider informing the
patient or their carer that the use is off-label.
Recommendation 2.1.9
Ensure use of a black triangle medicine in a PGD is exceptional, clearly stated
on the PGD and justified by best clinical practice.
Recommendation 2.1.10
Ensure use of a controlled drug in a PGD is legally permitted and justified by
best clinical practice.
Recommendation 2.1.11
Consider including an antimicrobial in a PGD only in exceptional
circumstances. Ensure that its use is clinically essential and will not jeopardise
local and national strategies to combat antimicrobial resistance.
Recommendation 2.1.12
Do not include complex medicines in a PGD, such as:

medicines needing frequent dosage adjustments, for example, warfarin

medicines needing frequent or complex monitoring, for example,
immunosuppressants

high-risk medicines, for example, insulin.
Recommendation 2.1.13
Do not use a PGD to make dose adjustments when a medicine is in a
patient’s possession.
Recommendation 2.1.14
Carefully consider the risks and benefits of including more than 1 medicine in
a PGD. Ensure all legal requirements are met for each medicine.
Recommendation 2.1.15
Do not use PGDs for managing complex long-term conditions, such as
hypertension or diabetes, or when establishing a diagnosis is complex in the
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associated setting.
1
2
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1
2
3.2
Obtaining agreement to develop a Patient Group
Direction
3
The GDG found evidence that PGDs need significant resources and are time-
4
consuming to produce. Some organisations had processes in place to obtain
5
the agreement of the authorising body for the PGD before proceeding to
6
develop the PGD. In other organisations this step appeared to be omitted from
7
the process.
8
When the local process included submitting a proposal to the authorising body
9
to develop a PGD, the GDG found examples of a number of proposal forms
10
being used for this purpose. The GDG found evidence that proposals were
11
submitted to a multidisciplinary ‘PGD approval group’, usually by a locally
12
determined clinical lead. This PGD approval group considered each proposal
13
and determined whether it was appropriate to proceed with developing a PGD
14
to deliver the service.
15
The GDG found evidence that the functions of the PGD approval group were
16
often fulfilled by an existing local medicines decision-making group, such as a
17
drug and therapeutics committee, or a sub-group. It agreed that the PGD
18
approval group did not have to be a separate decision-making group.
19
The GDG concluded that an effective PGD approval group should be in
20
operation with the delegated authority of the authorising body. There should
21
be clear lines of governance, reporting arrangements and accountability, such
22
as agreeing terms of reference, decision-making criteria and appropriate
23
documentation. Proposals to develop a PGD should only be accepted if they
24
comply with all legal requirements and professional guidance.
25
From the evidence identified, where PGD approval groups existed, their
26
functions did not always appear to be clearly defined. The GDG agreed that
27
an effective PGD approval group would have processes in place for:
28
 ensuring PGDs are not developed without previous agreement
29
 prioritising proposals to develop a PGD
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1
 seeking the views of stakeholders on proposals, for example, from clinical
2
groups, patients and the public and the commissioning or provider
3
organisation(s)
4
 gathering intelligence about local service delivery and exploring all the
5
options for prescribing, supplying and/or administering medicines in a
6
specific situation (see section 3.1)
7
8
9
 considering the arrangements for the security, storage, packaging and
labelling of medicines
 considering the resources needed to deliver the service, such as medicines
10
procurement from a licensed manufacturing unit and any diagnostic
11
equipment
12
13
14
 engaging with finance and commissioning to align decisions within the
framework of clinical commissioning
 considering the resources, training and competencies needed for
15
developing, authorising, using, monitoring, reviewing and updating the PGD
16
(see section 3.7)
17
 ensuring decision-making is robust and transparent with final decisions on
18
proposals formally recorded and communicated to appropriate
19
stakeholders.
20
The GDG agreed that clinical leads submitting proposals for developing PGDs
21
should have the opportunity to appeal a decision that is not in their favour
22
should they wish to (see figure 1). The appeals process should be clearly
23
documented, including timescales for appeal and this should be published on
24
the organisation’s website.
25
Evidence reviewed by the GDG indicated that the PGD approval group should
26
usually include the following people:
27
 prescribing or clinical governance lead
28
 medicines optimisation lead or chief pharmacist
29
 representative(s) from other local medicines decision-making groups.
30
If additional expertise is needed, other professionals who may need to be
31
invited include:
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1
 specialists with appropriate expertise to provide clinical advice in a specific
2
area, such as a local microbiologist (for PGDs containing an antibacterial)
3
or a paediatric specialist (for PGDs to be used for treatment in children)
4
 lead practitioner in the area in which the PGD is to be used
5
 controlled drugs accountable officer if the PGD uses a controlled drug
6
 service commissioner or provider, depending on local governance
7
arrangements
8
 finance lead.
9
The GDG was aware of multiple PGDs having been developed by different
10
teams, or in different settings for the use of the same medicine in the same
11
patient group across a single organisation. The GDG agreed that a single
12
PGD for a single medicine in a single patient group covering different services
13
in a single organisation would in most circumstances be more appropriate.
14
The GDG concluded that operating a PGD approval group may help to reduce
15
unnecessary duplication of PGDs.
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1
Recommendations
Recommendation 2.2.1
Establish a robust and transparent process for obtaining the authorising
body’s agreement before proceeding to develop a PGD. Ensure relevant
information is clear and easily accessible.
Recommendation 2.2.2
Ensure a multidisciplinary PGD approval group with a locally-defined mix of
members, considers proposals to develop a PGD. Define the roles and
responsibilities of members and consider their training and competency
needs.
Recommendation 2.2.3
Ensure governance arrangements for the PGD approval group are firmly
established, with clear lines of accountability and the delegated authority of
the authorising body. This should include:
 agreeing and documenting terms of reference
 setting the agenda and taking minutes of meetings
 prioritising PGD proposals
 establishing reporting arrangements
 engaging stakeholders, including patients and the public
 liaising with commissioning and finance.
Recommendation 2.2.4
Ensure the following information is considered and included in proposal
documentation to seek agreement to develop a PGD:
 the title of the PGD
 details of the proposer and other individual people who would be involved
in developing and authorising the PGD
 details of the organisation delivering the service (if this organisation is not
the authorising body)
 the setting where the PGD would be used
 the condition to be treated, considering patient inclusion and/or exclusion
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criteria
 benefits to patient care
 potential risks to patient safety
 details of medicine(s) to be supplied and/or administered, including dosage,
quantity, formulation and strength, route and frequency of administration,
duration of treatment and whether it is included in the local formulary
 health professional groups who would work under the PGD, including
training and competency needs
 current and/or future service provisions for supplying the medicine(s),
including its position within the care pathway
 evidence to support the proposal
 resources needed to deliver the service
 a timescale for developing the PGD.
Recommendation 2.2.5
Ensure adequate resources, such as finance, training, medicines procurement
and diagnostics are available for service delivery.
Recommendation 2.2.6
Establish a robust and transparent decision-making process that clearly
defines standard criteria for considering proposals to develop a PGD. Ensure
that:
 all legal requirements have been met
 robust local processes and clear governance arrangements are in place
 the risks and benefits of all options for supplying and/or administering the
medicine(s) have been explored and a PGD is the most appropriate option
for service delivery
 the PGD will deliver effective patient care that is appropriate in a predefined clinical situation, without compromising patient safety
 the views of stakeholders, such as clinical groups, patients and the public
and the provider or commissioning organisation are considered
 appropriate registered health professionals are available to use the PGD
and training and competency needs are addressed
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 people who are developing, authorising, monitoring, reviewing and
updating the PGD are identified and training and competency needs are
addressed
 the need for appropriately labelled packs and safe storage can be met
 adequate resources are available to ensure that processes are followed
within any locally agreed timeframe
 decisions are aligned with local clinical commissioning frameworks.
Recommendation 2.2.7
Record decisions to accept or reject the proposal, including the rationale for
the decision. Inform the person who submitted the proposal in writing, within a
locally agreed timeframe. Ensure the decision is communicated to other
appropriate stakeholders.
Recommendation 2.2.8
Establish and publish a robust and transparent process for appeals of
decisions made by the PGD approval group. Clearly define the acceptable
grounds and timescale for appeals.
1
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1
3.3
Developing Patient Group Directions
2
The GDG agreed that any development of a PGD should not proceed until the
3
PGD approval group, with the delegated authority of the authorising body, has
4
formally agreed that a PGD is appropriate (see section 3.2).
5
Responsibilities for developing Patient Group Directions
6
The GDG discussed evidence that the commissioning organisation may, or
7
may not be, the organisation that develops the PGD. A number of scenarios
8
may exist; see box 5 for examples.
9
Box 5. Examples of scenarios for developing PGDs.
Scenario 1:
A commissioning organisation, such as a CCG may develop and authorise
PGDs for use across several provider organisations, such as several GP
practices or community pharmacies.
Scenario 2:
An independent provider organisation may enter into arrangements to deliver
an NHS-commissioned service using PGDs, but is not able develop or
authorise the PGD independently of the commissioning organisation. This
may be because they do not have the resources needed to develop the PGD
and may not have the legal authority to authorise the PGD.
Scenario 3:
An independent provider organisation may develop its own PGDs to provide
an NHS-commissioned service, but may not have the legal authority to
authorise the PGD.
Scenario 4:
A provider organisation may develop and authorise its own PGDs to provide
an NHS-commissioned service, such as NHS trusts and some independent
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provider organisations.
Scenario 5
A commissioning organisation may not have the resources needed to develop
the PGD, although it may have the legal authority to authorise the PGD. In
these circumstances the necessary resources may need to be commissioned.
1
2
Process for developing PGDs
3
The GDG reviewed evidence that an individual PGD is usually developed by a
4
named ‘lead author’ who has overall responsibility. This author may be part of
5
a multidisciplinary ‘PGD working group’, which may operate virtually rather
6
than through face-to-face meetings.
7
The GDG reviewed evidence that members of the PGD working group should
8
usually include:
9
 a lead author
10
11
 a doctor (or dentist) – ideally the person signing off the PGD (see
section 3.4)
12
 a pharmacist – ideally the person signing off the PGD (see section 3.4)
13
 a representative of the professional group who will practice under the PGD
14
15
16
17
18
– ideally the person signing off the PGD (see section 3.4)
 a specialist with appropriate expertise, such as a specialist in microbiology
for PGDs containing an antibacterial
 the person responsible for ensuring that only fully trained and competent
professionals work under the PGD (see section 3.7).
19
The lead author may be the doctor (or dentist), pharmacist or representative
20
of the professional group who will practice under the PGD, or another person
21
such as the service lead. The roles and responsibilities of each person and
22
how they work together to develop the PGD should be determined locally and
23
clearly defined.
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1
The GDG recognised that these people may not all be available within an
2
organisation responsible for developing the PGD. The GDG concluded that in
3
these circumstances the authorising body should have clear governance
4
arrangements in place to ensure that people in the PGD working group have
5
the necessary knowledge, skills and expertise (see section 3.7).
6
Evidence also suggested that the training and competency of people involved
7
in developing PGDs was an important factor for local consideration (see
8
section 3.7).
9
The GDG concluded that it was good practice for commissioning and provider
10
organisations to collaborate when developing PGDs. The PGD working group
11
should be separate from, but would need to liaise with the PGD approval
12
group (see section 3.2). Other relevant stakeholders are likely to include
13
clinicians and other local medicines decision-making groups. Examples of
14
collaboration may include:
15
 identifying specialist expertise for a PGD working group
16
 seeking views on a draft PGD and incorporating relevant suggestions
17
 agreeing a final draft PGD before it is submitted for authorisation (see
18
section 3.4).
19
Presentation and content of Patient Group Directions
20
The GDG found many examples of local and national PGD templates that are
21
in use. It was aware that legislation requires that specific information must be
22
included in a PGD for it to be legally valid (see section 1.6). The GDG
23
concluded that the style, format and presentation of the PGD should be
24
determined locally, but this should be consistent across the organisation and
25
contain all the legally required information.
26
From the evidence identified, the GDG recognised that the use of medicines
27
included in a PGD should usually be consistent with the summary of product
28
characteristics (SPC). Updates to the PGD may be needed following changes
29
to the SPC (see section 3.6).
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1
The process for developing a PGD should include conducting a literature
2
search. The evidence identified should then be evaluated to assess its
3
relevance and validity. The GDG agreed that all relevant evidence used to
4
develop the PGD should be referenced, such as the SPC or NICE guidance
5
and potentially be included in an appendix to the PGD.
6
Evidence suggests PGDs should have an expiry date of 2 years. However,
7
the GDG agreed that this should be considered on an individual basis when
8
developing, reviewing and updating the PGD (see section 3.6).
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1
Recommendations
Recommendation 2.3.1
Ensure a named lead author has responsibility for developing the PGD,
supported by a locally determined multidisciplinary PGD working group.
Include the doctor (or dentist), pharmacist and other professional(s) signing
the PGD. Define their roles and responsibilities and consider their training and
competency needs.
Recommendation 2.3.2
Involve a specialist in microbiology when developing a PGD that includes an
antimicrobial.
Recommendation 2.3.3
Seek views on draft PGDs and agree final draft PGDs with relevant
stakeholders, including clinicians and local medicines decision-making
groups, when developing PGDs.
Recommendation 2.3.4
Include all legally required information in a PGD using a consistent style and
format across the organisation.
Recommendation 2.3.5
Use and reference the best available evidence, such as NICE guidance and
other sources of high-quality information when developing PGDs.
Recommendation 2.3.6
Ensure PGDs are consistent with the relevant summary of product
characteristics, unless the medicine is being used off-label (see
recommendation 2.1.8).
2
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1
3.4
Authorising Patient Group Directions
2
The GDG noted that legislation requires that:
3

a PGD must be signed by a doctor (or dentist) and a pharmacist
4

a PGD must be signed on behalf of the authorising body responsible
for the service, as set out in the legislation
5
6
7

health professionals who will be using the PGD must be named and
authorised to practice under it by the employing provider organisation.
8
See figure 1 for an overview of this process.
9
Responsibilities for authorising Patient Group Directions
10
The GDG discussed how healthcare is changing in the way it is delivered, with
11
increasing use of independent providers, such as community pharmacies and
12
community service providers who are social enterprises to deliver NHS
13
services. Local authorities have taken on responsibility for some public health
14
services, such as some sexual health services and smoking cessation.
15
The GDG agreed that lines of accountability between the provider and
16
commissioning organisation are at risk of becoming blurred. The GDG was
17
also aware of lengthy delays experienced by some provider organisations in
18
obtaining authorisation for a PGD from the commissioner, for example
19
out-of-hours service providers.
20
The GDG was also aware that a provider organisation may enter into
21
arrangements to deliver NHS-commissioned services using PGDs, but they
22
may not necessarily be able to develop or authorise PGDs independently of
23
the commissioning organisation.
24
The GDG recognised that in some circumstances both the provider and
25
commissioning organisation may be an authorising body. If the provider is an
26
authorising body, the commissioning organisation does not legally need to
27
authorise the PGDs for the provider. However, this should have been
28
identified when considering the need for a PGD to deliver the service (see
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1
section 3.1). The GDG concluded that whatever arrangements are agreed, the
2
commissioning organisation has a responsibility to ensure that governance
3
arrangements are in place and remain so (see section 3.8). The GDG agreed
4
than even when the provider may be legally able to authorise PGDs, they may
5
not have the necessary resources or expertise available.
6
The GDG recognised that in other circumstances, the provider organisation
7
may not be legally able to authorise their own PGDs if they are not listed as
8
an authorising body in the legislation. For example, independent hospitals and
9
independent clinics cannot legally authorise PGDs used to provide NHS-
10
commissioned services. The GDG was aware of the complexity in this area. It
11
concluded that organisations may in some circumstances need to review
12
whether their historic authorisation process was in line with legislation.
13
People signing the Patient Group Direction
14
When signing the PGD, the doctor (or dentist) and pharmacist take joint
15
responsibility and accountability for the accuracy of both the clinical and
16
pharmaceutical content of the PGD. The GDG agreed that this should be
17
undertaken by senior professionals with full consideration of the clinical
18
service in which the PGD is to be used.
19
When possible, the GDG agreed that a doctor (or dentist) and pharmacist
20
should be involved in developing the PGD. In addition, a representative of the
21
other professional group(s) who will practice under the PGD should also be
22
involved (see section 3.3).
23
Evidence suggested that a clinical governance lead in an NHS organisation is
24
usually responsible for signing the PGD on behalf of the authorising body.
25
This person has responsibility for ensuring that the PGD has been developed
26
in line with legislation (see section 1.6) and local organisational policies and
27
governance arrangements, with full consideration of the clinical service in
28
which the PGD is to be used. The GDG recognised that the decision to
29
authorise the PGD may be undertaken by the PGD approval group or other
30
locally determined medicines decision-making group. Nevertheless, an
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1
individual person should have designated responsibility for signing PGDs on
2
behalf of the authorising body.
3
This person is often a member of a local medicines decision-making group,
4
such as the chair of the drug and therapeutics committee. For governance
5
purposes, it may be advantageous if this person has not been involved in
6
developing the PGD. The GDG also agreed that it would be good practice for
7
this person also not to practice under the PGD.
8
The GDG discussed evidence that recommended that PGDs should also be
9
signed by a representative of the professional group(s) expected to supply
10
and/or administer the medicine(s) under the PGD. The GDG agreed that while
11
this is not required by legislation, in many circumstances this would continue
12
to constitute good practice.
13
The GDG also found evidence that PGDs may be developed for use across
14
multiple organisations, such as across several CCGs. In these circumstances,
15
the PGD would need to be authorised within each CCG.
16
Electronic signatures can be used when signing a PGD, providing guidance
17
issued by the Department of Health is followed.
18
In its review of the evidence, the GDG was aware that a PGD should be
19
reauthorised by the appropriate people after review and updating, even when
20
a review results in minimal or no changes (see section 3.6).
21
The GDG concluded that authorising bodies need to consider the knowledge,
22
skills and expertise needed by people who are authorising PGDs and ensure
23
that they are aware of their responsibilities and can demonstrate their
24
competency (see section 3.7).
25
Adopting the Patient Group Direction within the service
26
When the PGD has been signed by the appropriate people and is authorised
27
for use, clear local arrangements are needed that outline the ownership of,
28
and responsibility for, delivering the service. The PGD may need to be
29
‘adopted’ by the provider organisation(s) if they have not been involved in
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1
developing and authorising the PGD (see figure 1). For example, when a PGD
2
is developed and authorised by a CCG for use across multiple GP practices, a
3
process would need to be in place for each GP practice to adopt the PGD for
4
use in their practice.
5
Some commissioning organisations may ask the provider to co-sign the
6
commissioning organisation’s PGD to demonstrate that the provider has
7
accepted their responsibility, for example for authorising health professionals,
8
training and competency assessment and the monitoring and evaluation of
9
PGD use (see sections 3.7 and 3.8). The GDG agreed this would need to be
10
determined locally and clearly defined within local governance arrangements.
11
Evidence reviewed by the GDG suggests that organisations need to consider
12
how the authorised PGD is communicated and disseminated effectively to all
13
relevant stakeholders, for example, to the commissioning organisation if the
14
provider has developed and authorised the PGD. The GDG agreed that
15
organisations may consider publishing final signed versions of PGDs on an
16
intranet to allow health professionals using the PGD to be able to access the
17
most up-to-date version.
18
The GDG concluded that such arrangements would be case specific and for
19
local consideration. An individual person should be identified who will be
20
responsible for ensuring that effective communication occurs, such as a
21
service lead.
22
Named, eligible health professionals who will be using the PGD must be
23
authorised to practice under it by the employing provider organisation. For
24
example, a lead GP could authorise named practice nurse(s) to practice under
25
a PGD. The GDG agreed that provider organisations should designate an
26
appropriate person (for example, a clinical supervisor, line manager or GP) to
27
be responsible for authorising these health professionals. A record of the
28
health professionals authorised to practice under the PGD should be
29
maintained. In addition, authorised health professionals should sign the
30
appropriate documentation as an agreement to practice within the
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1
requirements of the PGD and that they are trained and competent to do so
2
(see section 3.5).
3
The GDG concluded that when the authorising body is not the employing
4
organisation, clear governance arrangements must to be in place to ensure
5
that only trained and competent health professionals are able to use PGDs
6
(see section 3.7).
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1
Recommendations
Recommendation 2.4.1
PGDs must be authorised only by an appropriate authorising body as set out
in the legislation.
Recommendation 2.4.2
Address barriers that may delay authorising PGDs, such as lack of clear
leadership and ownership, lack of understanding of legislation and
governance arrangements, and multiple PGDs for the same medicine in a
single organisation.
Recommendation 2.4.3
At an early stage, identify the appropriate senior doctor (or dentist) and senior
pharmacist who are to sign a PGD, in line with legislation. Define the roles
and responsibilities of these people and consider their training and
competency needs.
Recommendation 2.4.4
When acting as a doctor, dentist or pharmacist signatory, establish that the
clinical and pharmaceutical content is accurate and supported by the best
available evidence.
Recommendation 2.4.5
At an early stage, identify the appropriate person who is to sign a PGD as a
representative of any professional group(s) practising under the PGD.
Consider their training and competency needs.
Recommendation 2.4.6
At an early stage, identify the appropriate person who is to sign a PGD on
behalf of the authorising body, in line with legislation. Define the roles and
responsibilities of this person and consider their training and competency
needs.
Recommendation 2.4.7
When signing a PGD on behalf of an authorising body, establish that:
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 local processes and governance arrangements have been followed
 all legal requirements have been met.
Recommendation 2.4.8
Consider local needs and develop a communications plan to support the
dissemination of PGDs. Identify an appropriate person who is responsible for
ensuring this occurs.
Recommendation 2.4.9
For each PGD, the provider organisation should:
 identify a senior, responsible person from within the service to authorise
named registered health professionals to practice under the PGD
 maintain an up-to-date record of registered health professionals authorised
to practice under the PGD
 ensure authorised health professionals have signed the appropriate
documentation (see recommendation 2.5.2).
Recommendation 2.4.10
When a PGD is developed and authorised by a commissioning organisation
for use across multiple provider organisations, ensure it is adopted for use
within each provider organisation.
1
2
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1
3.5
Using Patient Group Directions
2
The GDG noted that PGDs must only be used by registered health
3
professionals listed in the legislation. In addition, individual health
4
professionals must be named on the PGD documentation and authorised to
5
work under the PGD by their employing organisation (see section 3.4). The
6
GDG was aware that some health professionals who work for different
7
provider organisations must be authorised within each organisation.
8
Health professionals who are eligible to work under a PGD require no
9
additional formal qualification. However, health professionals have a
10
professional responsibility to work within their competency and undertake
11
appropriate professional development in order to work safely with PGDs as
12
part of their professional practice. They should also follow local organisational
13
policies and act within their appropriate code of professional conduct and
14
governance arrangements.
15
Organisations should also ensure that appropriate training is available for
16
health professionals using PGDs (see section 3.7).
17
Evidence discussed by the GDG showed that even when a PGD is available
18
for use, it may not be appropriate to use it in every clinical situation. Health
19
professionals authorised to use PGDs need to make an informed decision
20
about whether the PGD is appropriate for an individual patient. This includes
21
recognising when an alternative intervention is preferred and when
22
signposting or referral to another health professional or provider is needed.
23
For example, a patient may meet the requirements of a PGD for
24
levonorgestrel for emergency hormonal contraception, but after discussion of
25
the available options, may prefer the option of an intra-uterine device.
26
When using a PGD, health professionals must ensure the patient meets the
27
criteria exactly, as determined by the PGD. If the patient does not meet the
28
criteria, the patient must be referred to another health professional or provider.
29
The GDG noted legislation states that these steps must be outlined in the
30
PGD.
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1
Individual health professionals are responsible for ensuring they are practising
2
under a PGD that is in-date and the most recent version. Organisations
3
should ensure PGDs in use are reviewed and updated, and that the most
4
recent version is communicated to health professionals and other relevant
5
stakeholders (see section 3.6).
6
The GDG was aware that POMs supplied to patients under a PGD should
7
contain the same labeling and other information that patients would otherwise
8
receive if the medicine had been supplied against a prescription. The GDG
9
concluded that local arrangements should ensure that medicines supplied
10
under a PGD should be in an appropriately labelled pack. Health
11
professionals supplying medicines should not break down these packs into
12
smaller units.
13
The GDG noted that a medicine supplied using a PGD must legally be
14
accompanied by the manufacturer’s patient information leaflet, even when the
15
medicine is being used off-label. The GDG agreed that it is also good practice
16
to provide a patient information leaflet when a medicine is administered using
17
a PGD, although this is not required by legislation.
18
From the evidence identified, the GDG recognised that medicines supplied to
19
patients under a PGD are subject to the payment of NHS prescription fees,
20
unless exemptions apply. The GDG was aware that medicines that are
21
administered are not subject to these fees.
22
The GDG was aware that in some circumstances the administrative burden of
23
collecting NHS prescription fees appeared to be a barrier. However, the GDG
24
concluded that local provider organisations should make arrangements for the
25
collection of the appropriate fees when medicines are supplied using a PGD.
26
Health professionals should also ensure the NHS prescription fees are
27
collected, when this is appropriate.
28
In its review of the evidence, the GDG noted that documentation relating to
29
the supply and/or administration of medicines under a PGD was often cited as
30
an area for improvement. It recognised the importance of appropriate
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1
documentation when using PGDs and agreed that it would be good practice
2
for the following details to be routinely recorded:
3
 date and time of supply and/or administration
4
 patient details, such as name, date of birth, allergies, previous adverse
5
events and how they met the criteria of the PGD
6
 details of medicine, such as name, strength, dose, frequency, route and
7
site (if by injection) of administration. The batch number and expiry date
8
should also be recorded for vaccines, blood-derived products and
9
parenteral medicines
10
 a statement that supply or administration is by using a PGD
11
 name and signature (which may be an electronic signature) of the health
12
professional administering or supplying the medicine
13
 relevant information, that was provided to the patient or their carer
14
 whether patient consent was obtained, in line with the Department of
15
Health’s advice on consent (2009).
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Recommendations
Recommendation 2.5.1
When supplying and/or administering medicines under a PGD, health
professionals should follow local organisational policies and act within their
code(s) of professional conduct and local governance arrangements.
Recommendation 2.5.2
Before practising under a PGD, health professionals should ensure they:
 have undertaken the necessary initial training and continuing professional
development
 have been assessed as competent and authorised to practice by the
provider organisation
 have signed the appropriate documentation
 are using a copy of the most recent and in-date version of the PGD
 have read and understand the context and content of the PGD.
Recommendation 2.5.3
When practising under a PGD, health professionals should:
 not delegate their responsibility
 ensure the patient meets the inclusion criteria exactly as set out in the
PGD
 ensure no exclusion criteria are present
 discuss alternative options for treating the patient’s condition, when
appropriate
 assess each individual patient’s circumstances and preferences
 recognise when signposting or referral to another health professional or
service is needed, as specified in the PGD
 understand relevant information about the medicine(s) included in the
PGD, such as:
 how to administer the medicine
 how the medicine acts within the body
 dosage calculations
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 potential adverse effects and how to manage them
 drug interactions, precautions and contraindications
 storage requirements
 follow-up arrangements
 be able to advise the patient or their carer about the medicine(s), as
appropriate.
Recommendation 2.5.4
When supplying a medicine(s), provide an appropriately labelled pack. Do
not split the pack.
Recommendation 2.5.5
Ensure the patient receives a manufacturer’s patient information leaflet with
each medicine.
Recommendation 2.5.6
Identify whether patients supplied with a medicine(s) under a PGD are
exempt from NHS prescription fees. Ensure the appropriate prescription
fee(s) is collected from patients who are not exempt.
Recommendation 2.5.7
Document the following information about the clinical assessment and supply
and/or administration of the medicine(s):
 date and time of supply and/or administration
 patient details, such as name, date of birth, allergies, previous adverse
events and how they met the criteria of the PGD
 details of medicine, such as name, strength, dose, frequency, route and
site (if by injection) of administration. The batch number and expiry date
should also be recorded for vaccines, blood-derived products and
parenteral medicines
 a statement that supply or administration is by using a PGD
 name and signature (which may be an electronic signature) of the health
professional administering or supplying the medicine
 relevant information, that was provided to the patient or their carer
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 whether patient consent was obtained, in line with the Department of
Health’s advice on consent (2009).
1
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1
3.6
Reviewing and updating Patient Group Directions
2
The GDG discussed that many organisations have a significant volume of
3
existing PGDs in use within their services. It was also aware that some
4
organisations have inherited PGDs from organisations that have merged or
5
cease to exist, as a result of transitional arrangements (see sections 1.6 and
6
3.4). Commissioning organisations may be responsible for PGDs in use by a
7
number of different providers.
8
The GDG recognised that the workload and resources needed to review and
9
update a large volume of PGDs was significant. However, PGDs must not be
10
used beyond their expiry date as any supply and/or administration of a
11
medicine(s) would be without legal authorisation.
12
The GDG concluded that all organisations with responsibility for PGDs should
13
establish and manage a work programme for reviewing, updating and
14
reauthorising PGDs within the legal requirements. The GDG’s view was that
15
review and updating should start at least 6 months before the expiry date of
16
the PGD to allow sufficient time to complete the process.
17
The Health Service Circular (HSC 2000/026) states that ‘generally, a direction
18
should be reviewed every two years’. However, the GDG was aware that this
19
was not required by legislation.
20
The GDG discussed the issue of the review date and agreed that in some
21
circumstances, it may be appropriate to update the PGD less frequently than
22
every 2 years. In other circumstances, a planned review period of less than
23
2 years may be necessary.
24
The GDG agreed that organisations need to carefully plan their work
25
programme and ensure that sufficient resources are available to review,
26
update and reauthorise their PGDs. It also agreed that staggering review
27
dates may help to support the work programme.
28
The GDG concluded that determining the expiry date for a PGD should be for
29
local consideration on a case-by-case basis, with patient safety paramount.
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1
The process for reviewing and updating a PGD should include a literature
2
search to identify new evidence. This then needs to be evaluated to assess its
3
relevance and validity. However, the GDG agreed the process for reviewing
4
and updating should not only consider the clinical and pharmaceutical content
5
of the PGD. The process should also include reviewing the delivery of the
6
service to assess whether the PGD remains the most appropriate option to
7
deliver the service (see section 3.1). The GDG found evidence of PGD use
8
being monitored and evaluated locally, before reviewing and updating the
9
PGD (see section 3.8).
10
The GDG also determined that the process should also allow for an
11
unscheduled review of a PGD earlier than the designated review date. This
12
should occur, for example, in response to the publication of relevant, valid,
13
new evidence, a change in the dosage regimen in the summary of product
14
characteristics (SPC), or a change in national guidance.
15
Evidence identified shows that PGDs are usually reviewed and updated by the
16
lead author, supported by a PGD working group (see section 3.3).
17
Reauthorisation of the updated PGD should follow the same process as the
18
original authorisation (see section 3.4). In addition, when the PGD is
19
reauthorised, the expiry date and record of health professionals authorised to
20
practice under the PGD must be updated and new documentation signed by
21
the health professionals authorised to practice under the PGD (see sections
22
3.4 and 3.5).
23
The GDG agreed that organisations need to ensure the updated PGD is
24
communicated and disseminated effectively to all relevant stakeholders (see
25
section 3.4).
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Recommendations
Recommendation 2.6.1
Establish and manage a structured work programme for reviewing, updating
and reauthorising PGDs. Ensure sufficient resources are available to deliver
the work programme.
Recommendation 2.6.2
Ensure a named lead author has responsibility for reviewing and updating the
PGD, supported by a locally-determined multidisciplinary PGD working group.
Define their roles and responsibilities and consider their training and
competency needs.
Recommendation 2.6.3
When reviewing the PGD, conduct a literature search to identify new
evidence. Ensure this evidence is evaluated to assess its relevance and
validity.
Recommendation 2.6.4
When reviewing the PGD, determine whether the PGD remains the most
appropriate option to deliver the service. This should be informed by local
monitoring and evaluations, frequency of use of the PGD, views of health
professionals working under the PGD and views of relevant stakeholders,
including patients or their carers.
Recommendation 2.6.5
Determine the expiry date for an individual PGD on a case-by-case basis, with
patient safety paramount.
Recommendation 2.6.6
Ensure an updated PGD is reauthorised, in line with legislation (see
recommendations 2.4.3 to 2.4.7).
Recommendation 2.6.7
When a PGD is updated, ensure all relevant documentation is also updated,
including the record and signatures of health professionals authorised to
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practice under the PGD.
Recommendation 2.6.8
Ensure an updated PGD is communicated and disseminated effectively to all
relevant stakeholders (see recommendation 2.4.8).
Recommendation 2.6.9
Establish a robust and transparent process for the unscheduled review and
updating of a PGD, when the need for this has been identified. This should
include responding to:
 changes in legislation or local organisations
 important new evidence or guidance that changes the PGD, such as new
NICE guidance
 new information on drug safety
 changes in the summary of product characteristics
 changes to the local formulary.
1
2
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3.7
Training and competency
2
In its review of the evidence, the GDG identified two key national resources to
3
support individual people and organisations in understanding their training and
4
competency needs:
5
 the national PGD website
6
 the competency framework included within ‘Patient Group Directions – a
7
practical guide and framework of competencies for all professionals using
8
patient group directions’, published by the National Prescribing Centre
9
(2009).
10
The GDG recognised that Health Service Circular (HSC 2000/026) states that
11
‘a senior person in each profession should be designated with the
12
responsibility to ensure that only fully competent, qualified and trained
13
professionals operate within directions’.
14
The GDG found that the training of health professionals in using PGDs
15
appeared to be an important consideration in some organisations, but not in
16
all. It found some examples of locally developed training resources that health
17
professionals needed to complete before being authorised to practice under
18
the PGD.
19
The GDG recognised the importance of continuous professional development
20
(CPD), and in particular that health professionals supplying and/or
21
administering medicines under a PGD are trained and assessed as competent
22
to do so. For example, health professionals who had not completed
23
appropriate training on administering injections may be legally able to
24
administer the injection under a PGD, but the GDG did not consider a PGD to
25
be an appropriate option without successful completion of additional training.
26
Prescribing or a Patient Specific Direction (PSD) should be used until the
27
appropriate training has been completed.
28
The GDG found fewer resources and limited consideration of the training
29
needs of the other people involved with PGDs, including:
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 members of the PGD approval group (see section 3.2)
2
 members of the PGD working group (see section 3.3)
3
 people authorising PGDs (see section 3.4)
4
 people authorising named health professionals to practice under the PGD
5
(see section 3.4).
6
The GDG also identified that some organisations may have people involved in
7
the PGD process who are not employed directly by the service or organisation
8
using the PGD. These people and organisations both have a responsibility to
9
ensure they are trained and competent.
10
The GDG agreed that appropriate training, regular re-training and assessment
11
of competency was needed for all people involved with PGDs, particularly if
12
and when their roles and responsibilities change. The GDG agreed that,
13
because the use of PGDs has become widely established, there is a need for
14
organisations to review their approach to training.
15
The GDG concluded that training and assessment of competency is essential
16
to reduce variation and deliver safe and effective services where PGDs are
17
used. Organisations should undertake a PGD training needs assessment and
18
establish a training programme that supports all people involved with PGDs.
19
In the absence of a comprehensive suite of nationally produced educational
20
materials, organisations may want to consider collaborating and sharing their
21
existing educational materials to ensure a comprehensive approach.
22
Knowledge, skills and expertise
23
The GDG considered that any person involved with PGDs will need
24
knowledge, skills and expertise in a number of specific areas as shown in
25
box 6.
26
27
Box 6. Knowledge, skills and expertise needed by all people involved
with PGDs.
 Relevant legislation
 Local processes and governance arrangements
 Professional and organisational standards
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 Current service provision
 Benefits and risks of all options for supplying and/or administering
medicines, including the purpose and intention of PGDs
 Interpretation of medicines information
 Collaborative working
 Information technology
 Records management, including version control.
1
2
If organisations do not have trained and competent people available for any
3
stage of the PGD process, they may want to consider commissioning or
4
collaborating with other organisations, or commissioning people with the
5
relevant competencies to provide the service.
6
The GDG considered that additional specialised knowledge, skills and
7
expertise are needed for people who are fulfilling specific roles in the process.
8
The GDG agreed that the ‘Local decision-making competency framework’,
9
produced by the National Prescribing Centre (2012), could be used to assess
10
the membership of the PGD approval group and identify any gaps in
11
competency.
12
The specialised knowledge, skills and expertise needed by individual people
13
and groups is listed in box 7.
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1
2
Box 7. Additional specialised knowledge, skills and expertise needed by
people in specific roles.
Role
Knowledge, skills and expertise
 Evidence gathering and critical appraisal
 Clinical and pharmaceutical knowledge, such as
drug interactions, contraindications and adverse
effects
 Authoring clinical content
 Medicines management systems, such as safe
storage, packaging and labelling
Doctor (or dentist)
 Relevant specialist clinical and pharmaceutical
signing a PGD
knowledge, including national guidance and policy
 Experience of working at a level of responsibility
appropriate to the role
 Experience of working in the clinical speciality or
service where the PGD is to be used
 Experience of working in a local medicines
decision-making group
Pharmacist signing a
 Relevant specialist clinical and pharmaceutical
PGD
knowledge, including national guidance and policy
 Experience of working at a level of responsibility
appropriate to the role
 Experience of working in the clinical speciality or
service where the PGD is to be used
 Experience of working in a local medicines
decision-making group
 Medicines management systems, such as safe
storage, packaging and labelling
Other people signing
 Experience of working at a level of responsibility
the PGD (representing
appropriate to the role
other professional
 Specialist practitioner in the clinical speciality or
group(s) using the
service where the PGD is to be used
PGD)
 Experience of working in a local medicines
decision-making group
A person signing the
 Organisational responsibility for clinical governance
PGD on behalf of the
 Experience of working in a local medicines
authorising body
decision-making group
People authorising
 Experience of working at a level of responsibility
named health
appropriate to the role in the relevant profession
professionals to
 Ability to incorporate relevant professional
practice under the PGD
standards
 Ability to incorporate appropriate training and
development for the relevant profession
People in the PGD
working group
3
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Recommendations
Recommendation 2.7.1
Identify the senior people in each profession who are responsible for ensuring
only fully competent, qualified and trained professionals operate within PGDs.
Recommendation 2.7.2
Undertake a local PGD training needs assessment.
Recommendation 2.7.3
Establish a comprehensive and appropriate training programme to meet the
identified training needs for all people involved in considering the need for,
developing, authorising, using and updating PGDs.
Recommendation 2.7.4
Ensure adequate educational materials are available to enable individual
people and organisations to deliver safe and effective services where PGDs
are used.
Recommendation 2.7.5
Consider collaborating with other organisations and sharing existing
educational materials to ensure a comprehensive approach.
Recommendation 2.7.6
Ensure training and re-training incorporates a post-training assessment of
competency.
2
3
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1
3.8
Organisational governance
2
3
The GDG was aware that models for delivering healthcare in the NHS are
4
currently changing. This guidance provides an opportunity for organisations to
5
review local policies and governance arrangements to support the safe and
6
effective use of PGDs. The GDG noted that not all organisations had
7
documented policies that described the PGD process across their
8
organisation. It agreed that robust and transparent processes need to be in
9
place for each stage of the process and these should be publicly available.
10
During its deliberations, the GDG recognised the importance of the
11
commissioning and provider organisation(s) working closely from an early
12
stage to incorporate the necessary governance arrangements covering each
13
step of the PGD process as outlined in figure 1. These governance
14
arrangements should establish clear lines of accountability and responsibility.
15
It is likely these will need to be considered on a case-by-case basis.
16
The responsibilities and reporting arrangements should be stated in a service
17
level agreement or contract specification. Key performance indicators (KPIs)
18
or quality metrics may be included. Arrangements should ensure providers
19
comply with ‘Essential standards of quality and safety’ published by the Care
20
Quality Commission (2010).
21
The GDG agreed that in order to ensure governance arrangements are
22
followed, a designated person in each organisation should have overall
23
organisational responsibility.
24
Patient safety incidents
25
The GDG agreed that governance arrangements should include the process
26
for reporting patient safety incidents, such as medication errors, near misses
27
and suspected adverse events. These arrangements should not replace
28
national patient safety reporting systems, including the yellow card scheme.
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1
The GDG concluded that governance arrangements should ensure patient
2
safety incidents are reported, collated and reviewed by the appropriate
3
organisations in a planned programme.
4
Monitoring and evaluation
5
In its review of the evidence, the GDG found that monitoring and evaluation of
6
PGD use helps to:
7
 ensure PGDs are used appropriately and deliver safe and effective care
8
 confirm that the PGDs are meeting both patient and service needs
9
 facilitate reflection on current practice.
10
The GDG was aware of resources available to support organisations with
11
monitoring and evaluation.
12
The GDG concluded that given the benefits of monitoring and evaluation in
13
the use of PGDs, as part of governance arrangements local organisations
14
should undertake such activities in a programme agreed locally between the
15
commissioner and provider.
16
Organisational records
17
The GDG acknowledged the importance of maintaining, storing and archiving
18
appropriate organisational records.
19
The Health Service Circular (HSC 2000/026) states that ‘there must be a
20
secure system for recording and monitoring medicines use from which it
21
should be possible to reconcile incoming stock and out-goings on a patient by
22
patient basis’ (see section 3.5).
23
All records and documentation relating to PGDs should comply with
24
information governance arrangements outlined in the Department of Health’s
25
code of practice on records management (2006), for example, data protection,
26
confidentiality and duration records should be securely stored.
27
The GDG agreed that it was good practice to maintain and review the
28
following records:
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1
2
 patient safety incidents, such as medication errors, near misses and
suspected adverse events
3
 minutes of the PGD approval group (see section 3.3)
4
 a list of all organisational PGDs that are in use, including their review date
5
and expiry date (see section 3.6)
6
 master authorised copies of PGDs (see section 3.4)
7
 expired versions of PGDs
8
 signatures of members of the PGD working group (see section 3.3)
9
 signatures of people signing a PGD (see section 3.4)
10
 training records (see section 3.7)
11
 results of monitoring and evaluation.
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Recommendations
Recommendation 2.8.1
Ensure local governance arrangements are firmly established between the
commissioning and provider organisation(s) with clear lines of accountability
and responsibility.
Recommendation 2.8.2
Ensure a designated person has overall organisational responsibility for
PGDs.
Recommendation 2.8.3
Comply with the Care Quality Commission’s ‘Essential standards of quality
and safety’.
Recommendation 2.8.4
Ensure patient safety incidents are reported, collated and reviewed by the
appropriate organisations in a planned programme.
Recommendation 2.8.5
Agree and undertake a planned programme of monitoring and evaluation of
PGD use.
Recommendation 2.8.6
Ensure appropriate organisational records are maintained, stored securely
and archived, in line with relevant legislation and the Department of Health’s
code of practice on records management. These records include:
 patient safety incidents, such as medication errors, near misses and
suspected adverse events
 minutes of the PGD approval group
 a list of all organisational PGDs that are in use, including their review date
and expiry date
 master authorised copies of PGDs
 expired versions of PGDs
 signatures of members of the PGD working group
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 signatures of people signing a PGD
 training records
 results of monitoring and evaluation.
1
2
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4
How this guidance has been developed
2
This good practice guidance was developed using the methodology described
3
in the Interim process statement – good practice guidance.
4
4.1
5
A Guidance Development Group (GDG) was formed to work with the NICE
6
project team. The recruitment process for both members and the group Chair
7
followed the NICE recruitment processes for committees and groups. See
8
appendix B for members of the GDG.
9
4.2
Guidance Development Group
Literature search strategy
10
A literature search was undertaken based on the scope of the guidance (see
11
appendix C for details of the literature search). The project team analysed the
12
search results and sifted the results for relevance. Evidence was identified
13
covering 5 main areas: guidance; legislation and policy; professional
14
standards and training; monitoring and evaluation; and local policies.
15
4.3
16
Additional evidence was also identified by the project team and GDG.
17
Following appraisal of the relevant published literature, the project team
18
conducted a gap analysis. The GDG reviewed the evidence and the project
19
team’s gap analysis.
20
The GDG concluded that a call for evidence from the NHS was not needed.
21
However, it recognised that amendments to medicines legislation relating to
22
PGDs were being prepared. The GDG agreed to invite a representative from
23
the Medicines and Healthcare products Regulatory Authority (MHRA) to join
24
the GDG as a co-opted member.
25
The GDG recognised that NHS services are provided using PGDs in many
26
different settings, including NHS-commissioned services provided by non-
27
NHS organisations. Many of these settings did not appear to be well
28
represented in the published literature, such as ambulance services, defence
Additional evidence
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medical services, police custody suites, prisons and independent health
2
providers.
3
The GDG agreed that the good practice recommendations would cover the
4
principles for considering the need for, developing, authorising, using and
5
updating PGDs, but these could not be tested out in all settings. However, the
6
GDG concluded that the project team would make informal contacts with an
7
appropriate number of these organisations to identify any issues specific to
8
their setting. From the evidence submitted, no additional issues were
9
identified that had not been considered by the GDG.
10
11
12
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Appendix A Glossary
2
Definitions for terms included in this glossary are for the purposes of this
3
guidance only.
4
Administer
5
To give a medicine by either:
6
 introduction into the body (for example, orally or by injection) or
7
 external application.
8
Appropriately labelled pack
9
In the majority of cases, the pack to be issued under a PGD will need to be
10
labelled to reflect the dose exactly as authorised in the PGD, as if it were
11
being dispensed against a prescription. In practice, the medicine will usually
12
have been over-labelled by a licensed manufacturing unit, leaving a space on
13
the pack for the patient’s name, date of dispensing and address of the
14
supplying service to be added at the time of supply.
15
Authorising body
16
An organisation listed in the legislation that is legally able to authorise a PGD
17
(see section 1.6). A commissioning and/or provider organisation may be an
18
authorising body.
19
Black triangle medicine
20
Black triangle medicines are licensed medicines that are intensively monitored
21
and subject to special reporting arrangements for adverse reactions.
22
Commissioning organisation/commissioner
23
The organisation with which a contract or agreement for the provision of a
24
service which may require the prescribing, supply or administration of
25
medicines has been made.
26
Contract specification
27
A description of the services and, if applicable, a brief description of the
28
deliverables to be provided under the contract.
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Delegation
2
Supply and/or administration of a medicine must not be assigned or delegated
3
to any other person under a PGD, regardless of their professional group or
4
level of training. For example, if the medicine is to be administered under a
5
PGD, such as influenza vaccination, this should be by the same health
6
professional that assessed the patient under the PGD.
7
Dispense
8
To make up or give out a clinically appropriate medicine to a patient for self-
9
administration or administration by another, usually a health professional. In
10
the case of POMs, dispensing must be in response to a legally valid
11
prescription. There is no legal distinction between ‘dispense’ and ‘supply’.
12
General Sales List (GSL) medicine
13
A medicine that may be sold in registered pharmacies and other lockable
14
retail outlets, such as supermarkets.
15
Independent medical agency
16
Under medicines legislation, an independent medical agency consists of, or
17
includes, the provision of services by medical practitioners. Legislation allows
18
independent medical agencies to develop and authorise PGDs for both
19
independent and NHS-commissioned services.
20
Independent prescribing
21
The prescriber takes responsibility for the clinical assessment of the patient,
22
establishing a diagnosis, the clinical management needed and prescribing.
23
Inherited PGDs
24
PGDs authorised by an authorising body that has merged or ceased to exist
25
and responsibility for the PGD is inherited by another authorising body. See
26
section 1.6.
27
Key performance indicators (KPIs)
28
KPIs are used to help define and measure progress towards organisational
29
goals.
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Licensed manufacturing unit
2
Medicines manufactured in the UK must be produced on a site that holds an
3
appropriate manufacturer's licence. Any person or organisation wishing to
4
wholesale deal (defined as selling, supplying or procuring to anyone other
5
than the end-user) medicinal products within the EU must hold a wholesale
6
dealer's licence.
7
Licensed medicine
8
A medicine which has a UK marketing authorisation.
9
Marketing authorisation
10
Medicines that meet the standards of safety, quality and efficacy are granted a
11
marketing authorisation (previously referred to as a ‘product licence’). This
12
authorisation covers all the main activities associated with the marketing of a
13
medicine. In the UK a marketing authorisation is granted by the Medicines and
14
Healthcare products Regulatory Agency (MHRA).
15
NHS-commissioned service
16
A service commissioned by the NHS or local authority, that may be provided
17
by an NHS organisation or a non-NHS organisation, such as:
18
 independent organisations, for example, independent hospitals
19
 independent contractors, for example, community pharmacies
20
 voluntary and charitable agencies, for example, hospices.
21
Non-medical prescribing
22
Non-medical prescribing includes independent prescribing by specially trained
23
nurses, pharmacists and optometrists working within their clinical competence
24
and supplementary prescribing by specially trained nurses, optometrists,
25
pharmacists, physiotherapists, podiatrists and radiographers.
26
Off-label use
27
Using a UK licensed medicine outside the terms of its marketing authorisation,
28
such as outside defined indications, doses, or routes of administration. For
29
example, when amitriptyline is used for neuropathic pain.
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Organisations
2
Use of the term ‘organisation’ in this guidance includes authorising bodies and
3
other organisations (both NHS and non-NHS providing NHS-commissioned
4
services).
5
Patient safety incident
6
Any unintended or unexpected incident that could have or did lead to harm for
7
1 or more patients receiving NHS-funded healthcare. This includes clinical
8
errors, medication errors, adverse events and near misses.
9
Patient Group Direction (PGD)
10
Defined in Health Service Circular (HSC 2000/026) as ‘A written instruction for
11
the supply or administration of medicines to groups of patients who may not
12
be individually identified before presentation for treatment’.
13
Patient Specific Direction (PSD)
14
Written instructions from an independent prescriber for a medicine to be
15
supplied and/or administered to a named patient.
16
PGD approval group
17
A locally determined multidisciplinary group that considers proposals to
18
develop a PGD to deliver a service. This group may also be involved at other
19
stages of the process, depending on local arrangements. For example, the
20
group may approve a final draft of the PGD before it is submitted for
21
authorisation. The term ‘PGD approval group’ is used for the purpose of this
22
guidance, but other names for the group may be used locally. The group may
23
be an existing local medicines decision-making group, such as the drug and
24
therapeutics committee, or subgroup.
25
PGD working group
26
A locally determined multidisciplinary group established for each individual
27
PGD. The PGD working group is responsible for developing the PGD and its
28
subsequent review and updating. The term ‘PGD working group’ is used for
29
the purpose of this guidance, but other names for the group may be used
30
locally.
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Pharmacy (P) medicine
2
A medicine that may be sold in registered pharmacies by a pharmacist or a
3
person acting under the supervision of a pharmacist.
4
Prescribe
5
To authorise in writing the supply and administration of a medicine, usually but
6
not necessarily a POM for a named patient.
7
Prescription-only medicine (POM)
8
A POM is generally subject to the restriction of requiring a prescription written
9
by an appropriate practitioner before it can be sold or supplied. There are
10
exemptions to requiring a prescription in some circumstances, such as using a
11
PGD.
12
Provider organisation/provider
13
The organisation responsible for providing the commissioned service which
14
may require the prescribing, supply or administration of medicines. This may
15
be an NHS organisation or a non-NHS organisation providing an NHS-
16
commissioned service.
17
Service level agreement (SLA)
18
An SLA is a written document that sets out an agreement between 2 or more
19
parties, describing the expectations and requirements of each party. An SLA
20
may describe a level of service expected by a commissioner from a provider,
21
the metrics used to measure the service, the obligations of the commissioner,
22
and what will happen if either party does not do what it has agreed to. It is
23
also likely to describe the communications and reporting lines between the
24
parties and the roles and responsibilities of each.
25
Special manufactured medicines
26
Special order unlicensed medicines, or ‘specials’, that are made to meet the
27
needs of an individual patient.
28
Summary of product characteristics (SPC)
29
The SPC is written information on a licensed medicine that must contain
30
certain numbered headings and information, such as, the indication(s),
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recommended dose(s), contraindications, and special warnings and
2
precautions for use.
3
Supplementary prescribing
4
A voluntary partnership between a doctor or dentist and a supplementary
5
prescriber, to prescribe within an agreed patient-specific clinical management
6
plan with the patient’s agreement.
7
Supply
8
To provide a medicine to a patient or carer for administration.
9
Unlicensed medicine
10
A medicine that does not have a UK marketing authorisation.
11
12
13
14
15
16
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Appendix B Key resources
2
3
British Medical Association (2010) Patient Group Directions and Patient
Specific Directions in general practice
4
5
Department of Health (2000) HSC 2000/026: Patient Group Directions
[England only]
6
7
Department of Health (2006) Medicines Matters: A guide to mechanisms for
the prescribing, supply and administration of medicines
8
9
Healthcare Improvement Scotland (2006) Patient Group Directions: Best
Practice Statement
10
Her Majesty’s Government (2012) The Human Medicines Regulations 2012
11
12
Medicines and Healthcare products Regulatory Agency (MHRA) (2010)
Patient Group Directions in the NHS
13
National Patient Group Direction website
14
15
16
National Prescribing Centre (2009) Patient Group Directions: a practical guide
and framework of competencies for all professionals using patient group
directions
17
18
National Prescribing Centre (2012) Local decision-making competency
framework
19
20
21
22
National Prescribing Centre Plus, Cheshire and Merseyside SHA, Greater
Manchester SHA, Cumbria and Lancashire SHA (2005). The safe supply and
administration of medicines. A resource to help train and support healthcare
professionals working with patient group directions
23
Nursing and Midwifery Council (2007) Standards for medicines management
24
25
Royal College of Nursing (2006) Patient Group Directions: guidance and
information for nurses
26
27
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Appendix C The Guidance Development Group and
2
NICE project team
3
Guidance Development Group
4
Angela Bussey
5
Principal Pharmacist Medicines Information Projects, Guy’s and St Thomas’
6
NHS Foundation Trust
7
Joyce Calam
8
Patient and Public Involvement representative
9
Martin England
10
Pharmacy Services Director, Ashtons Hospital Pharmacy Services
11
Katherine Gough
12
Head of Medicines Management, NHS Dorset
13
Alan Hughes
14
Governance Pharmacist, Betsi Cadwaladr University Health Board
15
Jonathan Mason (Chair)
16
Clinical Adviser (Medicines), NHS North East London and the City
17
Shelley Mehigan Raine
18
Nurse Specialist in Contraception, Dorset Healthcare University NHS
19
Foundation Trust
20
Ivor Nathan
21
Patient and Public Involvement representative
22
Julian Newell
23
Corporate Matron, Barnsley Hospital Foundation Trust
24
Stephen Riley
25
Clinical Support Pharmacist and Director, Medicines Optimisation Ltd
26
Anne Ryan
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Senior Policy Manager, Medicines and Healthcare products Regulatory
2
Agency
3
Helen Stubbs
4
Lead Adviser in Pharmaceutical Public Health, NHS Merseyside
5
Jane Swan (Deputy Chair)
6
Senior Medicines Management Adviser, Health Partnerships, Nottinghamshire
7
Healthcare NHS Trust
8
NICE project team
9
Professor Neal Maskrey
10
Project Lead (until 2 January 2013) and Consultant Clinical Adviser, NICE
11
Medicines and Prescribing Centre
12
Johanna Hulme
13
Project Lead (from 2 January 2013) and Associate Director Medicines Advice,
14
NICE Medicines and Prescribing Centre
15
Louise Picton
16
Senior Adviser Medicines Advice, NICE Medicines and Prescribing Centre
17
Ian Pye
18
Assistant Project Manager – Medicines Advice, NICE Medicines and
19
Prescribing Centre
20
Rebekah Robinson
21
Assistant Project Manager – Medicines Advice, NICE Medicines and
22
Prescribing Centre
23
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Appendix D Literature search
2
Search strategy
Search question
Sources
Search terms
Publication period
Restrictions
Inclusion criteria
Publication
What is the evidence/legislation relating to the use,
development and implementation of PGDs?
See sources searched below
‘Patient Group Direction or PGD’ and (see list of
requested search terms below)
Unlimited
English, UK based
Any relevant website, for local policies publication within
five years
Website, peer-reviewed journal
3
4
Search questions
5
6
Patient Group Direction(s) or Patient Group Directive(s) or PGD(s), covering
all providers and settings (NHS and non-NHS):
7
 use of PGDs
8
 authorisation/authorising PGDs
9
 local development/developing PGDs
10
 use of PGD competency framework
11
 legislation/medicines legislation
12
 governance/reporting/accountability
13
 guidance/professional standards/good practice
14
 training/education/competence
15
 service(s)/service provision/practice development
16
 safety/governance/risk
17
 clinical/pharmaceutical knowledge
18
 options for medicines supply – when is it appropriate/not appropriate to use
19
PGDs
20
 commissioning a PGD service
21
 restrictions/exemptions to using PGDs e.g. controlled drugs, unlicensed
22
23
24
and off-label medicines
 organisations providing/authorising PGDs/services using PGDs (including
non-NHS)
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 documentation
2
 review, updating, evaluation
3
 collaboration between organisations providing PGDs
4
5
6
7
8
Search string of health professionals: nurses; midwives; health visitors;
optometrists; pharmacists; chiropodists; radiographers; orthoptists;
physiotherapists; ambulance paramedics; dietitians; occupational therapists;
speech and language therapists; prosthetists, orthotists, dental hygienists and
dental therapists.
9
Sources searched
10
 Medline 1956–2012
11
 NHS Evidence Healthcare databases advanced search, databases
12
selected: AMDED, BNI, CINAHL, EMBASE, HEALTH BUSINESS ELITE,
13
HMIC, PsychINFO
14
 Cochrane Library Issue 11 2012
15
 NHS Evidence
16
 National Patient Group Direction website
17
 NICE
18
 MHRA (exemptions from Medicines Act restrictions)
19
 Google advanced search
20
 NHS Education for Scotland
21
 Health Education England
22
 British Medical Association
23
 Royal College of Nursing
24
 Royal Pharmaceutical Society
25
 General Pharmaceutical Council
26
 Department of Health
27
 College of Optometrists
28
29
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